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FDA 510(k)

UNIEXPERT 2 PLUS

K-Number: K200944 · 2020-05-26

ApplicantAdani
Decision Date2020-05-26
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UNIEXPERT 2 PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Adani. It received FDA 510(k) clearance on 2020-05-26 under 510(k) number K200944. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIEXPERT 2 PLUS?

UNIEXPERT 2 PLUS is a medical device that received FDA 510(k) clearance on 2020-05-26. The listed applicant is Adani. The 510(k) number is K200944.

When did UNIEXPERT 2 PLUS receive FDA 510(k) clearance?

UNIEXPERT 2 PLUS received FDA 510(k) clearance on 2020-05-26, under 510(k) number K200944.

Who is the listed applicant for UNIEXPERT 2 PLUS?

The FDA 510(k) record lists Adani as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIEXPERT 2 PLUS?

The FDA product code for UNIEXPERT 2 PLUS is KPR.

Other records listing Adani as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: KPR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.